MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT AR-SCOPE,30°4X152.5MM LGTH; ARTHROSCOPE AND ACCESSORIES

Model Number	C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/19/2024, it was reported by a sales representative via (b)(4) that an ar-3355-4030 scope has housing/threads that have unraveled.This occurred during use in a case with no patient affect.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the provided information, including the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is wear and tear of the device, as the manufacturing date is 06-may-2016.The complaint allegation was not confirmed as the customer's attached picture does not show the damage on the instrument.

• Brand Name: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19061352
• Report Number: 1220246-2024-01865
• Device Sequence Number: 5870080
• Product Code: HRX
• UDI-Device Identifier: 00888867029842
• UDI-Public: 00888867029842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• Device Catalogue Number: AR-3355-4030
• Device Lot Number: 10042020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown